Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

This study is not yet open for participant recruitment.
Verified June 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01614717
First received: June 6, 2012
Last updated: June 4, 2013
Last verified: June 2013

June 6, 2012
June 4, 2013
August 2013
July 2016   (final data collection date for primary outcome measure)
To Evaluate the Reverse Remodeling at 12 months post Implant [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary objective of the study is to evaluate the reverse remodeling due to a decrease in the LV mass (gr) associated to a reduction in resting LVOT gradient (mmHg) in hypertrophic obstructive cardiomyopathy patients with severe LVOT obstruction implanted with a CRT device at 12 months post-implant.
Same as current
Complete list of historical versions of study NCT01614717 on ClinicalTrials.gov Archive Site
Not Provided
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Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY
Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

This investigation is a prospective, randomized, parallel, blinded and multicenter design.

Randomization

  • Implant will be performed (Cardiac Resynchronization Therapy - Pacing (CRT-P) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D)). according current international certified guidelines.
  • Randomization will be stratified by the type of the device implanted (CRT-D or CRT-P)
  • Patients will be randomized 1:1 to either Treatment Group (Optimized DDD pacing) or Control Group (Back-up AAI pacing) during the first 12 months:
  • Treatment Group. The patient´s device is programmed to optimized DDD pacing
  • Control Group. The patient´s device is programmed to back-up pacing AAI.
  • After 12 months, the patients initially randomized to the Treatment Group (Optimized DDD Pacing) will go on in the same group. The patients initially randomized to Control Group (AAI Back-up Pacing) will be changed to the Treatment Group (Optimized DDD Pacing). And all the patients will be followed 12 months more.
  • The Echo Core Lab will be blinded to the group assigned.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Focus on Symptomatic Hypertrophic Obstructive Cardiomyopathy With Severe LVOT Obstruction
Device: CRT Implant
Patients will be implanted with CRT-D or CRT-P devices, then randomized to Treatment or Control Group
  • Treatment Group
    Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing
    Intervention: Device: CRT Implant
  • Control Group
    Patients randomized in the control Group will have the device programmed to back-up pacing AAI
    Intervention: Device: CRT Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
July 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unequivocal diagnosis of HCM, on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness ≥15 mm) and nondilated LV (LVEDD < 55mm) confirmed by a Core Lab Echo (Appendix I)
  • Peak LVOT gradient ≥50 mmHg under basal conditions, estimated by continuous wave Doppler, confirmed by a Core Lab Echo (Appendix I)
  • Presence of refractory symptoms (exertional dyspnea or chest pain) despite treatment with betablockers and/or verapamil (NYHA class II, III or IV).
  • Patients age is 18 years or greater
  • Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
  • Patients must be willing and able to comply with all study requirements

Exclusion Criteria:

  • Known causes of cardiac hypertrophy as infiltrative cardiomyopathy and severe hypertension
  • Permanent or persistent atrial fibrillation
  • Prior septal myectomy or septal ablation
  • Established indications for permanent pacing
  • Systemic disease that would preclude completion of the protocol
  • Limitations to correctly complete the study (physical, intellectual, logistical)
  • Patients with a life expectancy <24 months.
  • Patients who are or may potentially be pregnant.
Both
18 Years and older
No
Not Provided
Spain
 
NCT01614717
CR-11-030-EU-HF
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP